Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    15
  • sponsor
    Danae Hamouda, MD
Updated on 11 February 2022
cancer
serum pregnancy test
solid tumour

Summary

This is a single-center trial in subjects with pancreatic cancer and other advanced solid tumors. It is an open-label, single arm dose escalation Phase IB trial with subjects accrued in a 3 subject dose escalation cohort. Subjects with treated advanced solid tumors, and showing disease progression on established standard therapy, will be enrolled in this trial.

Description

This is a single-center trial in subjects with pancreatic cancer and other advanced solid tumors. It is an open-label, single arm dose escalation Phase IB trial with subjects accrued in a 3 subject dose escalation cohort. Subjects with treated advanced solid tumors, and showing disease progression on established standard therapy, will be enrolled in this trial.

C3 (Simvastatin + Digoxin + Metformin) will be given as three oral pills within recommended package insert safe levels. Subjects will be accrued in 3-subject dose escalation cohorts. 3 additional subjects will be treated at the presumptive maximum effective cohort dose/schedule for a total of 6 subjects at maximum effective level.

Details
Condition Advanced Pancreatic Cancer, Advanced Solid Tumor
Treatment Metformin, Simvastatin, Digoxin
Clinical Study IdentifierNCT03889795
SponsorDanae Hamouda, MD
Last Modified on11 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject 18 years with histologically confirmed solid tumor
Dose expansion subjects must have at least one tumor mass amenable to core needle biopsy
Refractory or intolerant to established standard of care
Have at least one tumor mass amenable to core needle biopsy. Adequate Archival Tissue required for patients that will take part in the dose escalation cohorts
ECOG performance status (PS) = 0-2, or Karnofsky PS 60%, or Lansky PS 60%
Normal organ and marrow function: absolute granulocyte count 1,000/mm3, absolute lymphocyte count 400/mm3, platelets 100,000/mm3, total bilirubin institutional upper normal limit, AST/ASL 2x institutional upper limit of normal, GFR >60 mL/min/1.73 m2 and creatinine <1.5 mg/dL
Subject has recovered to CTCAE Grade 1 or better from all adverse events associated with prior therapy or surgery. Pre-existing motor or sensory neurologic pathology or symptoms must be recovered to CTCAE Grade 2 or better
If female of childbearing potential, has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will then be required for study entry
Ability to understand and the willingness to sign a written informed protocol specific consent

Exclusion Criteria

Anti-cancer chemotherapy, biologic therapy or immunotherapy within 3 weeks or radiation therapy within 2 weeks of first infusion
Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected
Patients with only PET non-avid disease
Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for 2 months
Known history of rhabdomyolysis
History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the Investigator
Known HIV or chronic Hepatitis B or C infection
Have signs and symptoms consistent with an active infection
Live vaccination for the prevention of infectious disease administered <30 days prior to the start of study therapy or inactivated vaccination <14 days prior to the start of study therapy
History of severe allergic, anaphylactic, or other hypersensitivity reactions to Metformin, Simvastatin, and/or Digoxin
Patients diagnosed with Wolff-Parkinson-White Syndrome or electrocardiographic (ECG) pattern. Other cardiac conditions including: Previous MI with evidence of residual electrographic pattern consisted with bradycardia/heart block. Atrio-ventricular (AV) heart block (currently ongoing). History of ventricular fibrillation. Sick Sinus Syndrome or Sinus bradycardia thought to be caused by sinus node disease, unless effectively treated. Heart failure associated with preserved left ventricular ejection fraction, including constructive pericarditis, restrictive cardiomyopathy, and Amyloid heart muscle disease
Women of childbearing potential who are found to be pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or nursing
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